転移性扁平上皮または非扁平上皮非小細胞肺癌（NSCLC）患者を対象とした、ペムブロリズマブ（MK-3475）皮下投与（SC）とペムブロリズマブ静脈内投与（IV）をプラチナ製剤併用化学療法と併用した場合の比較試験（MK-3475-A86）

基本情報

NCT ID

NCT04956692

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

531

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.

対象疾患

介入

依頼者（Sponsor）

実施施設 (20)